Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05332613
Status
Recruiting
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Conditions

  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • TRE plus SOC — BEHAVIORAL
    Participants will undergo time restricted eating (TRE) each day for 12 weeks and will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
  • SOC — BEHAVIORAL
    Participants will be given lifestyle recommendations with respect to diet (500-1000 kcal) and moderate-intensity exercise (30 minutes).
  • TRE — BEHAVIORAL
    Participants will undergo time restricted eating (TRE) each day for 12 weeks plus 4 extra visits with the registered dietician and repeat Fibroscan, InBody composition scan, and MRI-PDFF.

Study Details

This study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, Mediterranean diet and 30 minutes of exercise on at least 5 days/week) on the degree of fat in the liver as measured by magnetic resonance imaging.

Key Dates

Start date
Apr 27, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: TRE plus SOC
    Participants will be required to fast each day for 12 weeks and will be given lifestyle recommendations with respect to diet and exercise. The registered dietitian (RD) will obtain a baseline dietary record and provide counseling on the time-restricted eating regimen. The RD will collect the participant's normal diet and exercise routine. Counseling will involve instructing the participant to choose an eight-hour eating window (e.g., 10:00am - 6:00pm) during which the participant will be able to eat. During the 16-house fasting window (e.g., 6:00pm - 10:00 am), the participant is able to drink regular water and black coffee or tea. The RD will be available to answer any questions the participants may have pertaining to the regimen and will instruct the participants regarding standard of care lifestyle recommendations. This includes education of a low-calorie diet (500-1000 kcal) and moderate-intensity exercise.
  • Active Comparator: SOC
    lifestyle modifications and weight management. Participants will be given lifestyle recommendations with respect to diet and exercise. The registered dietitian (RD) will obtain a baseline dietary record and provide counseling on the time-restricted eating regimen. A baseline dietary record will be assessed prior to fasting initiation with the RD in person. The RD will also collect the subject's normal diet and exercise routine. The RD will instruct the participants regarding standard of care lifestyle recommendations. This includes education of a low-calorie diet (500-1000 kcal) and moderate-intensity exercise.
  • Experimental: Crossover to TRE
    Participants who have not lost weight or have lost less than or equal to 5% of their body weight, they will be given the option to crossover to the TRE arm. Following the initial 12-week period and end of study MRI, participants would restart another identical 12-week cycle but adhering to the exact steps of the TRE arm including another 4 visits with the registered dieticians (RDs) and an end of study visit with repeat Fibroscan, InBody 770 body composition scan, and MRI-PDFF.

Primary Outcome Measure

Percentage of Patients Who Achieve At Least 30% Reduction in Liver Fat at 12 Weeks [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10021
Sonal Kumar, MD
[email protected]
6469625483
Lara Phipps
[email protected]
6469625483
Sonal Kumar, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine· New York, NY

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